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Effectiveness of intravenous r-tPA versus UK for acute ischaemic stroke: a nationwide prospective Chinese registry study

Wang, Xinhong, Li, Xiaoqiu, Xu, Yuming, Li, Runhui, Yang, Qingcheng, Zhao, Yong, Wang, Fengyun, Sheng, Baoying, Wang, Runqing, Chen, Shaoyuan, Wang, Lihua, Shen, Liying, Hou, Xiaowen, Cui, Yu, Wang, Duolao ORCID: https://orcid.org/0000-0003-2788-2464, Peng, Bin, Anderson, Craig S and Chen, Huisheng (2021) 'Effectiveness of intravenous r-tPA versus UK for acute ischaemic stroke: a nationwide prospective Chinese registry study'. Stroke and Vascular Neurology. (In Press)

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Abstract

BACKGROUND
Intravenous recombinant tissue plasminogen activator (r-tPA) and urokinase (UK) are both recommended for the treatment of acute ischaemic stroke (AIS) in China, but with few comparative outcome data being available. We aimed to compare the outcomes of these two thrombolytic agents for the treatment of patients within 4.5 hours of onset of AIS in routine clinical practice in China.

METHODS
A pre-planned, prospective, nationwide, multicentre, real-world registry of consecutive patients with AIS (age ≥18 years) who received r-tPA or UK within 4.5 hours of symptom onset according to local decision-making and guideline recommendations during 2017-2019. The primary effectiveness outcome was the proportion of patients with an excellent functional outcome (defined by modified Rankin scale scores 0 to 1) at 90 days. The key safety endpoint was symptomatic intracranial haemorrhage according to standard definitions. Multivariable logistic regression was used for comparative analysis, with adjustment according to propensity scores to ensure balance in baseline characteristics.

RESULTS
Overall, 4130 patients with AIS were registered but 320 had incomplete or missing data, leaving 3810 with available data for analysis of whom 2666 received r-tPA (median dose 0.88 (IQR 0.78-0.90) mg/kg) and 1144 received UK (1.71 (1.43-2.00)×10 international unit per kilogram). There were several significant intergroup differences in patient characteristics: r-tPA patients were more educated, had less history of stroke, lower systolic blood pressure, greater neurological impairment and shorter treatment times from symptom onset than UK patients. However, in adjusted analysis, the frequency of excellent outcome (OR 1.18, 95% CI 1.00 to 1.40, p=0.052) and symptomatic intracranial haemorrhage (OR 0.70, 95% CI 0.33 to 1.47, p=0.344) were similar between groups.

CONCLUSIONS
UK may be as effective and carry a similar safety profile as r-tPA in treating mild to moderate AIS within guidelines in China. REGISTRATION: http://www.clinicaltrials.gov. unique identifier: NCT02854592.

Item Type: Article
Subjects: QV Pharmacology > Hematologic Agents > QV 190 Drugs affecting blood coagulation
WL Nervous System > WL 300 General works (Include works on brain alone)
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI): https://doi.org/10.1136/svn-2020-000640
Depositing User: Julie Franco
Date Deposited: 14 May 2021 13:51
Last Modified: 04 Jun 2021 10:34
URI: https://archive.lstmed.ac.uk/id/eprint/17797

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